AUTH/2815/12/15: AbbVie v Piramal — Sevoflurane “drop test” leaflet treated as promotional; missing cost, AE statement and date | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/2815/12/15
Parties	AbbVie v Piramal Healthcare UK Ltd
Material	Leaflet detailing a drop test of Sevoflurane Piramal screw-top glass bottles (ref MKT-SEV-025)
Product	Sevoflurane (Sojourn Sevoflurane 100% Inhalation Vapour Liquid referenced by Piramal; UK PL 29595/0002)
Main issue	Leaflet ruled promotional; missing cost, mandatory AE reporting statement, and date drawn up/last revised
Complaint received	22 December 2015
Case completed	6 May 2016
Applicable Code year	2015
Breach clauses	Clause(s) 4.1, 4.9, 4.10, and 9.1
No breach clauses	Clause(s) 2
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

AbbVie complained about a Piramal leaflet describing a “drop test” of Sevoflurane Piramal screw-top glass bottles (ref MKT-SEV-025), including test method/results and pages reproducing HCP and patient information.
AbbVie alleged the leaflet was promotional and omitted required particulars: cost, date drawn up, and the adverse event (AE) reporting statement; and that high standards were not maintained.
Piramal argued the leaflet was not promotional because it focused on packaging quality/robustness rather than clinical safety/efficacy, and said it had been withdrawn in November 2015 (though this was not made clear during inter-company dialogue).
The Panel considered that packaging is part of the medicine and could influence choice; therefore claims about packaging (including reference to a 5-year shelf life) fell within promotion.

⚖️

⌄

The leaflet was ruled to be promotional and therefore subject to the Code.
Breach ruled for missing cost information (as part of prescribing information requirements).
Breach ruled for missing mandatory AE reporting statement.
Breach ruled for missing date of preparation/last revision.
Breach ruled for failure to maintain high standards.
No breach of Clause 2 (Panel considered an additional Clause 2 ruling would be disproportionate in the circumstances).

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access